FDA Grants IQuum Emergency Use Authorization (EUA) for 2009 H1N1 Influenza Assay for CLIA 'Moderate and High Complexity' Certified Laboratories
Liat Influenza A/2009 H1N1 Assay identifies the 2009 H1N1 Influenza virus starting from collected samples in less than 30 minutes.
Marlborough, MA, May 10, 2010 – IQuum, Inc. today announced it has been granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Liat Influenza A/2009 H1N1 Assay. The assay detects and differentiates 2009 H1N1 influenza viral RNA starting from collected nasopharyngeal swab samples in less than 30 minutes. The entire nucleic acid testing process from sample to result is automated on the Liat Analyzer. The authorization allows IQuum’s Liat Influenza A/H1N1 Assay to be used in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform "moderate complexity" (not waived) tests, enabling use in hospital near-patient settings.
“IQuum’s Liat system is aimed at bringing a high-performance nucleic acid test to largely the same level of simplicity and speed as rapid immunoassays,” said Dr. Shuqi Chen, Chief Executive Officer of IQuum. “The ability to perform nucleic acid testing while a patient is waiting and receive reliable results immediately is highly significant for pandemic preparedness, clinical decision making, and public health.”
The 2009 H1N1 is an influenza A virus that emerged in April 2009. This novel influenza virus spread widely and has become the predominant circulating influenza strain in the U.S. In response to the worldwide spread of this novel influenza, the World Health Organization further raised the pandemic alert level to Phase 6 in June 2009, the first time the organization has done so in 40 years.
The Liat Influenza A/H1N1 Assay automates and integrates sample purification, RT-PCR amplification, and real-time detection of the 2009 H1N1 viral RNA from nasopharyngeal swab specimens. The test targets a conserved region of the matrix gene of influenza A viral RNA and the hemagglutinin gene of 2009 H1N1 influenza viral RNA, along with an internal process control to ensure the quality of results. The assay’s turnaround time is less than 30 minutes. Yet, the Liat assay demonstrated 100% positive percent agreement and 100% negative percent agreement (lower 95% confidence interval: 90.1% positive agreement; 92.9% negative agreement) with a comparator EUA assay in 85 clinical samples tested, including 35 samples positive for 2009 H1N1.
About the Liat Analyzer
The Liat system refines the testing process to three simple steps: (1) collecting a raw biological sample into a Liat Tube, (2) scanning the tube’s barcode to identify the test and track the patient sample, and (3) inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required. The Liat Analyzer’s small size (~4.3” x 8” footprint), fully integrated and self-contained design, along with its closed tube design and robust error prevention features, will make it ideally suited for future tests near-patient or on-site molecular diagnostics. IQuum’s ultimate goal with the Liat system is to enable nucleic acid tests to be conducted rapidly and reliably by non-specialized personnel at the near patient or other decentralized settings.
About the FDA's Emergency Use Authorization
The U.S. Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA has issued emergency use authorizations to make diagnostic tools available to public health and medical personnel for use in the diagnosis of 2009 H1N1 influenza virus under certain circumstances.
The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved and uncleared medical products following a determination and declaration of emergency, provided certain criteria are met. The FDA can only grant emergency use authorization for the duration of the emergency, which is currently set to expire on June 23, 2010, unless it is terminated sooner or renewed. The FDA may also revoke an EUA prior to the termination of the emergency.
About IQuum, Inc.
IQuum is the leader in developing lab-in-a-tube technology, a novel biological sample testing platform which provides revolutionary benefits to a broad cross section of the bioassay market. The Company's proprietary technology enables the non-specialized personnel to perform more sophisticated biological sample testing in any setting with greater speed. Founded in 1998, the Company is commercializing its lab-in-a-tube technology and products for the clinical diagnostics, bio-defense, and industrial testing markets. For more information, please visit www.IQuum.com.
This Release contains forward-looking statements, including statements regarding IQuum and development of IQuum’s products. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. IQuum undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.
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